Novosti
Khirurgii

 This journal is
indexed in Scopus
journal cover
android icon Android Applicaion

Year 2021 Vol. 29 No 3

GENERAL & SPECIAL SURGERY

A.V. KOROTKIKH 1, 2, A.M. BABUNASHVILI 3, A.L. KALEDIN 4, R.V. AKHRAMOVICH 5, V.V. DERKACH 6, R.M. PORTNOV 6, A.V. SOZYKIN7

ANALYSIS OF INTERMEDIATE RESULTS OF A COMPARATIVE MULTICENTER RANDOMIZED TENDERA STUDY INVESTIGATING THE DISTAL RADIATION ACCESS

Regional Clinical Hospital No1 1, Tyumen,
Amur State Medical Academy 2, Blagoveshchensk,
Center for Endosurgery and Lithotripsy 3, Moscow,
I.I. Mechnikov North-West State Medical University4, St. Petersburg,
Mytishchi City Clinical Hospital 5, Mytishchi,
Clinic of Innovative Surgery 6, Klin
Central Clinical Hospital of the Russian Academy of Sciences 7, Moscow,
The Russian Federation

Objective. To prove the safety and efficacy of distal radial artery (DRA) puncture for endovascular interventions versus the traditional forearm radial artery (RA) puncture site by comparing immediate and long-term results.
Methods. In 2017, a multicenter, open, randomized (1:1) study TENDERA (Comparison between Traditional Entry Point and Distal Puncture of Radial Artery) was started. During 2 years, 520 patients were included, mean age 63.4±10.0 years. The observation group (DRA puncture) included 271 patients, the comparison group (RA puncture) – 249 patients. The study included both stable patients and those with NSTEMI: the observation group – 39 (14.4%), the comparison group – 34 (13.7%), p=0.809. The primary endpoint is immediate (hospital) or late radial thrombosis. Secondary endpoints are: 1 – composite point, complications from the access artery; 2 – puncture parameters.
Results. The average difference in the diameters of the RA and DRA was 0.3 mm and 0.4 mm, in some patients the DRA diameter corresponded to the RA or even exceeded it. The diameter of RA and DRA in men and women significantly differs, 2.65±0.44 mm and 2.36±0.36 mm (p=0.001), 2.31±0.39 mm and 2.13±0.38 mm (p=0.001). Technical success of DRA access requre the number of attempts. 94.1% – the percentage of successful cardiac catheterization performed through the distal radial artery approach, which is significantly less than via RA – 100% (p<0.001). In the observation group, significantly fewer rebleedings and rehemostasis were occured. In the long-term period, there were registered outstandingly more hematomas in the observation group at the time of discharge and after 1 week.
Conclusion. Intermediate analysis of the results of the TENDERA study shows that there is no significant difference in the primary endpoint, but the number of complications in the observation group associated with the puncture markedly – hematoma more than 5 cm to the day of discharge and after 7 days.

Keywords: radial access, distal radial access, research, percutaneous coronary intervention, acute coronary syndrome, coronary heart disease, radial artery
p. 285-295 of the original issue
References
  1. Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Jüni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferović PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO. 2018 ESC/EACTS Guidelines on myocardial revascularization. Euro Intervention. 2019 Feb 20;14(14):1435-34. doi: 10.4244/EIJY19M01_01
  2. Valgimigli M, Gagnor A, Calabró P, Frigoli E, Leonardi S, Zaro T, Rubartelli P, Briguori C, Andò G, Repetto A, Limbruno U, Cortese B, Sganzerla P, Lupi A, Galli M, Colangelo S, Ierna S, Ausiello A, Presbitero P, Sardella G, Varbella F, Esposito G, Santarelli A, Tresoldi S, Nazzaro M, Zingarelli A, de Cesare N, Rigattieri S, Tosi P, Palmieri C, Brugaletta S, Rao SV, Heg D, Rothenbühler M, Vranckx P, Jüni P; MATRIX Investigators. Radial versus femoral access in patients with acute coronary syndromes undergoing invasive management: a randomised multicentre trial. Lancet. 2015 Jun 20;385(9986):2465-76. doi: 10.1016/S0140-6736(15)60292-6
  3. Hamon M, Pristipino C, Di Mario C, Nolan J, Ludwig J, Tubaro M, Sabate M, Mauri-Ferré J, Huber K, Niemelä K, Haude M, Wijns W, Dudek D, Fajadet J, Kiemeneij F; European Association of Percutaneous Cardiovascular Interventions; Working Group on Acute Cardiac Care of the European Society of Cardiology; Working Group on Thrombosis on the European Society of Cardiology. Consensus document on the radial approach in percutaneous cardiovascular interventions: position paper by the European Association of Percutaneous Cardiovascular Interventions and Working Groups on Acute Cardiac Care and Thrombosis of the European Society of Cardiology. Euro Intervention. 2013 Mar;8(11):1242-51. doi: 10.4244/EIJV8I11A192
  4. Korotkikh AV, Bondar VYu. Using a deep palmar branch of radial artery in the ragion of anatomical snuffbox during angiography. Dal’nevostoch Med Zhurn. 2016;(1):24-27. http://www.fesmu.ru/dmj/20161/2016105.aspx (In Russ.)
  5. Petroglou D, Didagelos M, Chalikias G, Tziakas D, Tsigkas G, Hahalis G, Koutouzis M, Ntatsios A, Tsiafoutis I, Hamilos M, Kouparanis A, Konstantinidis N, Sofidis G, Pancholy SB, Karvounis H, Bertrand OF, Ziakas A. Manual versus mechanical compression of the radial artery after transradial coronary angiography: the memory multicenter randomized trial. JACC Cardiovasc Interv. 2018 Jun 11;11(11):1050-58. doi: 10.1016/j.jcin.2018.03.042
  6. Amato JJ, Solod E, Cleveland RJ. A “second” radial artery for monitoring the perioperative pediatric cardiac patient. J Pediatr Surg. 1977 Oct;12(5):715-17. doi: 10.1016/0022-3468(77)90399-2
  7. Kaledin AL, Kochanov IN, Seletskii SS, Arkharov IV, Burak TIa, Kozlov KL Peculiarities of arterial access in endovascular surgery in elderly patients. Uspekhi Gerontologii. 2014;27(1):115-19. https://pubmed.ncbi.nlm.nih.gov/25051767/?from (In Russ.)
  8. Oliveira MDP, Navarro EC, Kiemeneij F. Distal transradial access as default approach for coronary angiography and interventions. Cardiovasc Diagn Ther. 2019 Oct;9(5):513-19. doi: 10.21037/cdt.2019.09.06
  9. Frolov AA, Sorokin IN, Sharabrin EG, Bekhterev AV, Frolov IA, Savenkov AG. Comparison of traditional and distal radial approach in percutaneous coronary interventions. Kardiologiia i Serdechno-Sosudistaia Khirurgiia. 2019;12(5):410-17. doi: 10.17116/kardio201912051410 (In Russ.)
  10. Kim Y, Lee JW, Lee SY, Bae JW, Lee SJ, Jeong MH, Lee SH, Ahn Y. Feasibility of primary percutaneous coronary intervention via the distal radial approach in patients with ST-elevation myocardial infarction. Korean J Intern Med. 2021 Mar;36(Suppl 1):S53-S61. doi: 10.3904/kjim.2019.420
  11. Hadjivassiliou A, Cardarelli-Leite L, Jalal S, Chung J, Liu D, Ho S, Klass D. Left distal Transradial Access (ldTRA): a comparative assessment of conventional and distal radial artery size. Cardiovasc Intervent Radiol. 2020 Jun;43(6):850-57. doi: 10.1007/s00270-020-02485-7
  12. Rajah GB, Lieber B, Kappel AD, Luqman AW. Distal transradial access in the anatomical snuffbox for balloon guide-assisted stentriever mechanical thrombectomy: technical note and case report. Brain Circ. 2020 Feb 18;6(1):60-64. doi: 10.4103/bc.bc_22_19. eCollection 2020 Jan-Mar.
  13. Kühn AL, Rodrigues KM, Singh J, Massari F, Puri AS. Distal radial access in the anatomical snuffbox for neurointerventions: a feasibility, safety, and proof-of-concept study. J Neurointerv Surg. 2020 Aug;12(8):798-801. doi: 10.1136/neurintsurg-2019-015604
  14. Sgueglia GA, Di Giorgio A, Gaspardone A, Babunashvili A. Anatomic Basis and Physiological Rationale of Distal Radial Artery Access for Percutaneous Coronary and Endovascular Procedures. JACC Cardiovasc Interv. 2018 Oct 22;11(20):2113-19. doi: 10.1016/j.jcin.2018.04.045
  15. Coomes EA, Haghbayan H, Cheema AN. Distal transradial access for cardiac catheterization: A systematic scoping review. Catheter Cardiovasc Interv. 2020 Dec;96(7):1381-89. doi: 10.1002/ccd.28623
  16. Boumezrag M, Ummat B, Reiner J, Venbrux A, Sarin S. Pseudoaneurysm: a rare complication of distal transradial access in the anatomical snuffbox. CVIR Endovasc. 2019 Jun 29;2(1):21. doi: 10.1186/s42155-019-0064-2
  17. Nairoukh Z, Jahangir S, Adjepong D, Malik BH. Distal Radial Artery Access: The Future of Cardiovascular Intervention. Cureus. 2020 Mar 7;12(3):e7201. doi: 10.7759/cureus.7201
  18. Hadjivassiliou A, Kiemeneij F, Nathan S, Klass D. Ultrasound-guided access to the distal radial artery at the anatomical snuffbox for catheter-based vascular interventions: a technical guide. Euro Intervention. 2021 Mar 19;16(16):1342-48. doi: 10.4244/EIJ-D-19-00555
Address for correspondence:
675001, Russian Federation,
Blagoveshchensk, Gor’kii Str., 97,
Amur State Medical Academy
of the Ministry of Health of Russia,
Cardiac Surgery Clinic,
tel. +7 922 079 06 22,
e-mail: ssemioo@rambler.ru,
Korotkikh Alexandr V.
Information about the authors:
Korotkikh Aleksandr V., Head Physician, Cardiovascular Surgeon, Specialist in X-ray Endovascular Diagnosis and Treatment, Cardiac Surgery Clinic, Amur State Medical Academy, Blagoveshchensk, Russian Federation.
https://orcid.org/0000-0002-9709-1097
Babunashvili Avtandil M., MD, Professor, Head of the Vascular Center, Center for Endosurgery and Lithotripsy, Moscow, Russian Federation.
https://orcid.org/0000-0003-2269-7059
Kaledin Alexandr L., PhD, Surgeon of the unit of X-ray endovascular methods of diagnosis and treatment, I.I. Mechnikov North-West State Medical University4, St. Petersburg, Russian Federation.
https://orcid.org/0000-0003-0581-6132
Akhramovich Ruslan V., Physician of X-ray Endovascular Diagnosis and Treatment Mytishchi City Clinical Hospital, Mytishchi, Russian Federation.
https://orcid.org/0000-0002-0026-6998
Derkach Vladislav V., Head of the Endovascular Surgery unit, Clinic of Innovative Surgery, Klin, Russian Federation.
https://orcid.org/0000-0002-0367-3628
Portnov Roman M., Physician of X-ray Endovascular Diagnosis and Treatment, Clinic of Innovative Surgery, Klin, Russian Federation.
https://orcid.org/0000-0001-5360-3815
Sozykin Alexey V., MD, Professor of the Cardiology Department, N.I. Pirogov Russian National Research Medical University, Head of the Unit of X-ray Endovascular Methods of Siagnosis and Treatment, Central Clinical Hospital of the Russian Academy of Sciences, Moscow, Russian Federation
https://orcid.org/0000-0002-2570-5758
Contacts | ©Vitebsk State Medical University, 2007-2023